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IRCT20130311012781N5 IRCT 2020-08-25 Ahvaz University of Medical Sciences Effect of Colchicine on secondary prevention of ischemic stroke Evaluation the efficacy of colchicine on secondary prevention of ischemic stroke in patients with atrial fibrillation (AF) 2020-06-21 anticipated 20 Complete https://irct.ir/trial/50342 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of randomization is bolck in this study. The randomized codes will be produced for 100 patients and then patients will be specified in active and control gruop according to randomization list, Blinding description: participants, principle investigator ، healthcare providers , data collectors ,outcome assessors، data safty and monitoring board and manuscript writers are all blinded in our study. Patients will be divided into group A and B by a person who is unaware of the patients clinical information by the randomization list. The patients will be treated and followed up according to produced protocol for a year. 2 Ischemic stroke.. Intervention 1: All patients will be treated wih the rivaroxaban at the appropriate of dose once daily for a year. Patients will be additionally treated with colchicine at the dose of 0.5 mg twice daily for a year in intervention group. The colchicine tablet will be produced from mofid pharmacy company. Patients will be followed up every three months for a year. Intervention 2: All patients will be treated wih the rivaroxaban at the appropriate of dose once daily for a year. Patients will be additionally treated with placebo twice daily for a year in control group. The placebo tablet will be produced from mofid pharmacy company. Patients will be followed up every three months for a year. Yes - There is a plan to make this available What will be shared: The primary clinical outcome of participants will be shared by the analysis of collected data. When: 6 months after publication of results To whom: available for people who working in academic institutions Conditions: Primary clinical outcome of participants will be shared by tables and charts. Where to obtain: Davood kashipazha _ Department of Neurology of Golestan Hospital in Ahvaz. Email: dakashi47@gmail.com How to obtain: Please your request will be send by email. our response will be send you by email during a month. Comments:
public Davood kashipazha
Farvardin Ave., Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3012 dakashi47@gmail.com Ahvaz University of Medical Sciences scientific Davood kashipazha
Farvardin Ave., Golestan blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3012 dakashi47@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients who are admitted with a diagnosis of ischemic stroke and have AF at the time of hospitalization The considered age group is 18 years or older no limit no limit Both Allergies and sensitivities to colchicine Patients who are taking corticosteroids, methotrexate, TNFa-blockers, interleukin1 -1b antagonist Patients with inflammatory disease such as lupus, rheumatoid arthritis, connective tissue disease or chronic infections Patients with sever Renal failure ( GFR <30 ml/min/1.73 m2) or liver failure (ALT/AST > 2 above normal Patients with moderate to severe cytopenia (plt < 100000, neutrophil count < 1500) or blood dyscrasia Patients who are contraindicated for rivaroxaban Pregnant or lactating women or women in childbearing age who do not take appropriate contraception Treatment - Drugs Placebo All patients will be treated wih the rivaroxaban at the appropriate of dose once daily for a year. Patients will be additionally treated with colchicine at the dose of 0.5 mg twice daily for a year in intervention group. The colchicine tablet will be produced from mofid pharmacy company. Patients will be followed up every three months for a year. All patients will be treated wih the rivaroxaban at the appropriate of dose once daily for a year. Patients will be additionally treated with placebo twice daily for a year in control group. The placebo tablet will be produced from mofid pharmacy company. Patients will be followed up every three months for a year. Recurrence of stroke. Timepoint: 3, 6, 9 and 12 months after the beginning of study. Method of measurement: Clinical history and imaging finding. Department Research and technology, Ahvaz jundishapur university of medical sciences Approved 2020-02-24 Ethics committe of ahvaz university of medical sciences Esfand Ave., golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)